Onsite GMP Technical Writer for Quality Docs

LNN Pace Analytical Life Sciences, LLC

United States

On-site

USD 70,000 - 95,000

Full time

4 days ago
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Benefits offered by this job

Medical
Dental Vision
401K retirement savings plan
Life insurance

Job summary

Pace Life Sciences in Oakdale, MN is seeking a full-time onsite Technical Writer to author and maintain GMP documentation in a regulated lab. The role collaborates with Operations, Laboratory, QA, and Program Management to ensure accurate, inspection-ready records and support investigations, CAPAs, and change controls.

Responsibilities include drafting SOPs, deviations, and change controls while ensuring data integrity and regulatory compliance.

Qualifications

  • Bachelor’s degree in Life Sciences or related field with 3+ years in regulated environments.
  • Familiarity with cGMP, GDP, FDA regulatory expectations, and data integrity required.
  • Experience authoring, editing, and maintaining GMP documentation in contract testing labs.

Responsibilities

  • Author, edit, and coordinate GMP documentation (SOPs, work instructions, quality records).
  • Draft investigation reports, deviations, CAPAs, change controls, and OOS/OOT docs.
  • Translate complex lab data into clear, compliant technical documentation.
  • Support audit readiness and CAPA/change control activities with cross-functional teams.
  • Review content for accuracy, consistency, and inspection readiness.

Skills

Authoring
Editing
Documentation
Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

eQMS
Microsoft Office
Electronic document management systems

Job description

Pace Life Sciences in Oakdale, MN is seeking a full-time onsite Technical Writer to author and maintain GMP documentation in a regulated lab. The role collaborates with Operations, Laboratory, QA, and Program Management to ensure accurate, inspection-ready records and support investigations, CAPAs, and change controls.

Responsibilities include drafting SOPs, deviations, and change controls while ensuring data integrity and regulatory compliance.

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